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Impact of Alpha Lipoic Acid Efficacy in Burning Mouth Syndrome

Primary Purpose

Burning Mouth Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Lipoid acid gel
Placebo
Sponsored by
University of Catania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burning Mouth Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: clinically diagnosed with BMS who reported a history of continuous oral burning pain for more than 4 months with no clinical signs that could justify the syndrome Exclusion Criteria: clinically diagnosed with BMS who reported a history of continuous oral burning pain for more than 4 months with no clinical signs that could justify the syndrome

Sites / Locations

  • AOU Policlinico G. RodolicoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Lipoic acid gel

Placebo

Arm Description

Patients were treated with a topic gel of lipoic acid

Patients treated with a placebo gel control

Outcomes

Primary Outcome Measures

Evolution of burning mouth
Evolution of burning mouth symptoms change through a questionnaire

Secondary Outcome Measures

Full Information

First Posted
February 6, 2023
Last Updated
February 6, 2023
Sponsor
University of Catania
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1. Study Identification

Unique Protocol Identification Number
NCT05729529
Brief Title
Impact of Alpha Lipoic Acid Efficacy in Burning Mouth Syndrome
Official Title
Impact of Alpha Lipoic Acid Efficacy in Burning Mouth Syndrome Using a Topical Gel
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2020 (Actual)
Primary Completion Date
May 25, 2023 (Anticipated)
Study Completion Date
May 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Catania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A double-blind placebo-controlled trial is conducted in order to evaluate the efficacy of alpha lipoic acid (ALA) and determine the statistical significance of the outcome variables. Burning mouth syndrome (BMS) is defined as an oral burning sensation in the absence of clinical signs which could justify the syndrome. Recent studies suggest the existence of neurological factors as a possible cause of the disease.
Detailed Description
A double-blind placebo-controlled trial is conducted in order to evaluate the efficacy of alpha lipoic acid (ALA) and determine the statistical significance of the outcome variables. 60 patients with BMS, in two groups: case group with 600 mg/day and placebo as control group; with a follow-up of 2 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burning Mouth Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The main objective of this study was to evaluate the efficacy of lipoic acid over placebo in the management of BMS
Masking
ParticipantInvestigator
Masking Description
Sealed envelopes
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lipoic acid gel
Arm Type
Active Comparator
Arm Description
Patients were treated with a topic gel of lipoic acid
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients treated with a placebo gel control
Intervention Type
Other
Intervention Name(s)
Lipoid acid gel
Intervention Description
Topic lipoid acid gel used with topic oral gel used on tongue
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo oral gel used on tongue
Primary Outcome Measure Information:
Title
Evolution of burning mouth
Description
Evolution of burning mouth symptoms change through a questionnaire
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: clinically diagnosed with BMS who reported a history of continuous oral burning pain for more than 4 months with no clinical signs that could justify the syndrome Exclusion Criteria: clinically diagnosed with BMS who reported a history of continuous oral burning pain for more than 4 months with no clinical signs that could justify the syndrome
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gaetano Isola
Phone
0953785652
Email
gaetano.isola@unict.it
First Name & Middle Initial & Last Name or Official Title & Degree
Rosalia Leonardi
Email
rleonardi@unict.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaetano Isola
Organizational Affiliation
Università degli Studi di Catania
Official's Role
Principal Investigator
Facility Information:
Facility Name
AOU Policlinico G. Rodolico
City
Catania
ZIP/Postal Code
95124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaetano Isola, DDS
Phone
+3909537800

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Study protocol
IPD Sharing Time Frame
1 year
IPD Sharing Access Criteria
Pubmed

Learn more about this trial

Impact of Alpha Lipoic Acid Efficacy in Burning Mouth Syndrome

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